Phase I/II Combination With Irinotecan- Erbitux

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

38

Participants

Timeline

Start Date

May 31, 2008

Primary Completion Date

December 31, 2012

Study Completion Date

December 31, 2012

Conditions
Metastatic Colorectal Cancer (MCRC)
Interventions
DRUG

Cetuximab

IV solution, IV, QW, 400 mg/m2 X 1, followed by 250mg/m2, until progression

DRUG

Irinotecan

IV solution, IV, Q3W, 350 mg/m2, until progression

DRUG

Brivanib

Oral, Tablet, QD, (200 mg, 400 mg, 600 mg, 800 mg dose escalation) until progression

DRUG

Brivanib

Oral, Tablet, QD, MTD determined in Arm 1, Phase 1, until progression

DRUG

Brivanib Placebo

Oral, tablet, QD, until progression

Trial Locations (12)

5000

Local Institution, Odense C

17176

Local Institution, Stockholm

20141

Local Institution, Milan

28050

Local Institution, Madrid

40202

James Graham Brown Cancer Center, Louisville

47014

Local Institution, Meldola Fc

63110

Washington University, St Louis

75185

Local Institution, Uppsala

90033

Usc/Norris Comprehensive Cancer Center Hospital, Los Angeles

Usc/Norris Comprehensive Cancer Center, Los Angeles

C1426ANZ

Local Institution, Buenos Aires

135-710

Local Institution, Seoul

Sponsors
All Listed Sponsors
lead

Bristol-Myers Squibb

INDUSTRY

NCT00594984 - Phase I/II Combination With Irinotecan- Erbitux | Biotech Hunter | Biotech Hunter